From the evidence reported above it is a small step to the evaluation of VNS for treatment of clinical depressions in nonepileptic patients. Recently, Rush et al. (2000) published their findings from a first single-arm study on this issue. On the basis of ethical considerations, only the most affected patients from different clinics in Dallas were included and provided with a vagus nerve stimulator (n = 30). Inclusion criteria were a DSM-IV diagnosis of major depression disorder (MDD), bipolar I or bipolar II disorder (American Psychiatric Association, 1994). Patients had to be in a major depressive episode (MDE) which either was lasting > 2 years or which was one of at least four MDEs during life. Finally, they had to have failed on at least two antidepressant medication treatments from different medication groups during the current MDE.
The study design was as follows: the baseline period was up to 4 weeks before implantation. Implantation was followed by a 2-weeks recovery period with the stimulation device turned off. During these weeks patients were left unclear about whether the device was already turned on or not. During the next 2 weeks output currency was increased stepwise to the maximum tolerated level (ramp-up period). In the following 8 weeks stimulation was left unchanged (fixed-stimulation period). After implantation patients were evaluated for mood states every week. The main outcome score was the Hamilton Depression Rating Scale (28-item version, HDRS-28; Hamilton, 1960, 1967). A subsequent open clinical observation period lasted at least 9 months in all patients reported on.
No effects were obtained during the first 2 weeks after implantation (recovery period with inactive stimulator). Using a > 50% reduction in the HDRS-28 total score to define response, a 40% response rate was found at the end of the 8-weeks fixed stimulation period. Complete response (HDRS-28 < 10) was observed in 17% of the patients. Follow-up data from the open clinical observation period showed sustained mood improvement in all responders. In some cases response was further increased so that at the end of the reported observation period, 7 of 10 responders from the acute study demonstrated complete response (23% of the total sample).
Since the depressions were very severe and chronic, a mere placebo effect was very unlikely to occur; even with the lack of a control group and despite the small sample size these findings are intriguing and justify further investigations. From a clinical point of view, these data raise hope for a totally new approach in the treatment of severe clinical depressions, and a multisite double-blind randomized control trial is underway in the USA in which more than 200 severely depressed patients will enrol.
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